Total Functional Assessment Of Cancer Therapy-General Research Articles

Quality of life for patients with advanced gastrointestinal cancer randomised to early specialised home-based palliative care: the ALLAN trial

BackgroundThe primary aim of specialised palliative care (SPC) is to improve the quality of life (QoL) for patients with a high symptom burden from a life-threatening disease. This randomised study aimed to assess the QoL impact of early integration of SPC alongside tumour-specific palliative treatment in patients with gastrointestinal (GI) cancers.MethodsWe randomly assigned ambulatory patients with advanced GI cancer to early integration of SPC and palliative tumour-specific treatment or tumour-specific treatment alone. The primary endpoint was QoL assessed at baseline and every sixth week using the Functional Assessment of Cancer Therapy—General (FACT-G) questionnaire.ResultsA total of 118 patients were randomised. The difference in total FACT-G score between patients assigned to early integration with SPC and controls was 5.2 points (95% CI: −0.1 to 10.5, p = 0.216), 6.7 points (95% CI: 0.2 to 13.3, p = 0.172), and 13 points (95% CI: 5.7 to 20.2, p = 0.004) at weeks 6, 12, and 24, respectively.ConclusionsThis prospective randomised trial strengthens the argument for early integration of SPC with tumour-specific treatment in patients with advanced GI cancers. We found an improved QoL for patients with advanced GI cancer 24 weeks after randomisation to early integration of home-based SPC.Clinical trial registrationClinicalTrials.gov (ref: NCT02246725).

Evaluating the Effectiveness of Geriatric-Specific Cancer Rehabilitation Programs on Patient Health Outcomes.

This study evaluated a specialized rehabilitation program's impact on senior cancer patients' quality of life. one hundred and thirty patients aged ≥65 years with various cancer types undergoing/recovering from treatment were enrolled in oncology clinics in Al-Ahsa, Saudi Arabia. The intervention arm (n=65) participated in a tailored geriatric cancer rehabilitation program. The control group (n=65) received standard oncology care. The Functional Assessment of Cancer Therapy-General (FACT-G) tool assessed the quality of life across physical, social, emotional, and functional domains. T-tests and multivariate regression analyses compared outcomes. Total FACT-G scores showed a significantly higher quality of life for the geriatric cancer rehabilitation group versus standard care. Rehabilitation patients also demonstrated meaningful improvements across physical, social, and functional subscales. Rehabilitation involvement was the most predictive factor for optimized outcomes. Specialized geriatric cancer rehabilitation meaningfully improved several quality of life domains in older patients over standard care. Despite persistent barriers, rehabilitation programming optimized older cancer patients' physical and psychosocial health. Oncology and geriatrics must collaborate to ensure evidence-based rehabilitation access meets older cohorts' unique needs.

Quality of Life and Global Response Score in Cutaneous T-Cell Lymphoma

Background: Cutaneous T-cell lymphoma (CTCL) encompasses a heterogenous group of conditions that are typically incurable and managed as chronic, life-long diseases. Clinically, CTCL is associated with pruritus, and skin lesions that can cause pain and cosmetic discomfort, resulting in reduced health-related quality of life (HRQoL) for patients. As these patients often receive life-long therapy, any proposed therapy should maximize therapeutic safety and efficacy as well as patient HRQoL. Improvement in HRQoL may provide an indication to continue therapy, even for patients with partial response. Clinical trial response assessments for CTCL utilize a global response score, which includes skin, nodal and blood assessments (Olsen et al, JCO 2011). Dermatology-specific instruments, such as Skindex-29 (Chren 2012, Dermatol Clin 30), and oncology-specific instruments such as the Functional Assessment of Cancer Therapy - General (FACT-G) (Cella et al, JCO 1993), have been used to assess quality of life in this population. Disease entity, stage, age, sex, education, and treatment regimen are related to the extent of HRQOL impairment in patients with CTCL (Porkert et al, EJC 2018). Correlation between clinical response and HRQoL response has been reported in other cancers, such as renal cell carcinoma (Grimm Oncol Ther 2017) and other dermatologic conditions such as psoriasis (Acta Derm Venereol 2017), but has not been reported in CTCL. We evaluated changes in HRQoL in relation to the global response score in CTCL. Methods: Global response data, as well as Skindex-29 and FACT-G scores, were obtained from the phase III MAVORIC study (Kim et al, Lancet Oncol 2018). Patients with stage IB-IVB mycosis fungoides or S ézary syndrome were prospectively enrolled. Global response score was assessed every 8 weeks. Skindex-29 and FACT-G questionnaires were administered every 8 weeks. Patients with at least a baseline value for Skindex-29 or FACT-G score, at least one subsequent visit with both Skindex-29 or FACT-G value, and an overall response value were included. Changes in scores were calculated from baseline to the first visit with best overall response. A higher score in Skindex-29 indicated worse HRQoL. A higher score on FACT-G indicated improvement in HRQoL. Wilcoxon rank-sum test was performed. Correlation was calculated by Pearson coefficient. Results: 324 patients were evaluable for total Skindex-29 analysis. First visit with best overall response for patients with PD/SD occurred at a median of 1.26 cycles (IQR; 1.26, 14.26); 5.98 cycles (IQR; 1.26, 48.98) for PR; and 10.98 cycles (IQR; 3.98, 36.98) for CR. Patients with CR/PR as best response (n=121) had median change in Skindex-29 of -16 (IQR; -31, -8) and patients with SD/PD as best response rate had median change in Skindex-29 of -4 (IQR; -12, 3) (p <0.001) (Table 1). 333 patients were evaluable for total FACT-G analysis. Patients with CR/PR as best response rate had median change in FACT-G of 6 (IQR; -2, 16) and patients with SD/PD as best response rate had median change in FACT-G of 2 (IQR; -6, 8) (p <0.001) (Table 1). Skindex-29 correlates with global response score overall and across all domains. FACT-G correlates with global response score overall and across all domains, with the exception of social well-being. There was a moderate reverse correlation between change in total Skindex-29 and change in total FACT-G score (R=-0.61, p<0.001) (Figure 1). Conclusion: HRQoL as measured by the Skindex-29 and FACT-G correlate with complete or partial response to therapy in the global response score in patients with CTCL. There is moderate correlation between skin-specific quality of life and general quality of life in this population. Further exploration of factors affecting social well-being in patients with CTCL is warranted. Incorporation of QOL scales in global response score criteria should be considered.

Frontline Management Strategy and Quality of Life in Follicular Lymphoma: A Multi-Institutional Prospective Cohort Study

Background: Understanding the symptoms and quality of life (QOL) over time of adults with follicular lymphoma (FL) is important for treatment decision-making and clinical management. However, there are limited population-level data on the long-term QOL of adults with FL. We aim to describe the real-world, long-term QOL of adults with newly diagnosed FL up to 5/6 years after diagnosis. Methods: We used the Mayo Clinic/Iowa Molecular Epidemiology Resource (MER) and the multi-institutional Lymphoma Epidemiology of Outcomes (LEO) to identify adults with grade 1-3A FL who completed QOL surveys at baseline and follow-up. Participants with lymphoma were prospectively enrolled within 9 months of diagnosis in the MER cohort from 2002-2015 and within 6 months of diagnosis in the multi-institutional LEO cohort study across 8 cancer centers from 2015-2020. The LEO/MER cohort studies systematically collected information on disease status, QOL, health behaviors, and functional assessment. Treatments, disease relapses, and deaths were verified by medical record review. Treating physicians determined clinical management. QOL was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) at years 1, 2, 3, and 5/6 post-diagnosis. A higher FACT-G total score (range 0-108) indicated better QOL across 4 subscales (range): physical (0-28), social/family (0-28), emotional (0-24), and functional (0-28) well-being. We categorized participants based on their frontline management at time of diagnosis: “observation” (surveillance), “treatment” (systemic treatment with immunotherapy +/- chemotherapy), and “local” (radiation) groups. We employed a generalized linear mixed model to evaluate and compare the changes in QOL scores (as a continuous variable) from baseline for the observation, treatment, and local groups, adjusting for sex, race/ethnicity, age, FLIPI risk, and cohort (i.e., LEO or MER). We also evaluated QOL changes by FLIPI risk. Results: Our study included 1,544 participants with FL and QOL data. At the time of enrollment, median age was 61 years (range 19-91), 88% were non-Hispanic White, and 49% were female. Based on initial management, 529 (34%) were in the observation group, 880 (57%) were in the treatment group, and 135 (9%) were in the local group. FLIPI risk was high for 17% in the observation group, 29.3% in the treatment group, and 3% in the local group. The mean (standard deviation) baseline FACT-G total score was lowest in the treatment group with the following baseline scores: 86 (13) for the observation group, 83 (14) for the treatment group, and 88 (12) for the local group (Table 1). The observation and local groups reported a greater worsening of their baseline FACT-G total score vs the treatment group at both the 2-year (-1.2, -0.8 vs +1.8, respectively) and 5/6 year (-5.4, -6 vs. -1.6, respectively) timepoints (Figure 1). This appeared to be driven by worsened physical and functional well-being in the observation (-1.3, -2.2, respectively) and local (-0.9, -2.4, respectively) groups vs the treatment group (0, -0.3, respectively). These differences were statistically significant between the observation vs treatment groups. There were no statistically significant differences in the other subscales, i.e., social/family and emotional well-being, by frontline management. Social/family well-being decreased across all groups by 5/6 years (-2.3 in observation, -2.2 in treatment, and -3 in local, p<0.05). Regardless of FLIPI risk, the total FACT-G scores decreased within each FLIPI risk group at 5/6 years (-4.4 for low, -3.8 for intermediate, and -4.9 for high, p<0.05). This was primarily due to worsened social/family well-being (-2.4 for low, -2.2 for intermediate, and -3 for high, p<0.05) at 5/6 years. There was no statistically significant difference in QOL between FLIPI risk groups. Conclusion: This is one of the first and largest studies with real-world longitudinal QOL data for FL. Our study suggests that frontline systemic treatment initially improved QOL and resulted in a lower degree of QOL decline over time. Social/family well-being decreased over time regardless of frontline management or FLIPI risk. Further research is warranted to explore the impact of timing and specific systemic treatments on QOL, incorporate the patient/caregiver experience to address social/family well-being, and identify the clinical significance of our findings.

Associations between symptoms with healthcare utilization and death in advanced cancer patients

IntroductionThere is limited data about assessments that are associated with increased utilization of medical services among advanced oncology patients (AOPs). We aimed to identify factors related to healthcare utilization and death in AOP.MethodsAOPs at a comprehensive cancer center were enrolled in a Center for Medicare and Medicaid Innovation program. Participants completed the Edmonton Symptom Assessment Scale (ESAS) and the Functional Assessment of Cancer Therapy–General (FACT-G) scale. We examined factors associated with palliative care (PC), acute care (AC), emergency room (ER), hospital admissions (HA), and death.ResultsIn all, 817 AOPs were included in these analyses with a median age of 69. They were generally female (58.7%), white (61.4%), stage IV (51.6%), and represented common cancers (31.5% GI, 25.2% thoracic, 14.3% gynecologic). ESAS pain, anxiety, and total score were related to more PC visits (B=0.31, 95% CI [0.21, 0.40], p<0.001; B=0.24 [0.12, 0.36], p<0.001; and B=0.038 [0.02, 0.06], p=0.001, respectively). Total FACT-G score and physical subscale were related to total PC visits (B=−0.021 [−0.037, −0.006], p=0.008 and B=−0.181 [−0.246, −0.117], p<0.001, respectively). Lower FACT-G social subscale scores were related to more ER visits (B=−0.03 [−0.53, −0.004], p=0.024), while increased tiredness was associated with fewer AC visits (B=−0.039 [−0.073, −0.006], p=0.023). Higher total ESAS scores were related to death within 30 days (OR=0.87 [0.76, 0.98], p=0.027).ConclusionsThe ESAS and FACT-G assessments were linked to PC and AC visits and death. These assessments may be useful for identifying AOPs that would benefit from routine PC.

Exploring Perception of Terminally Ill Cancer Patients about the Quality of Life in Hospice based and Home based Palliative Care: A Mixed Method Study.

The objectives of the study were to evaluate the perceptions and performance of terminally ill cancer patients regarding the quality of palliative care at different settings and to measure their quality of life (QOL) at the end of life. This comparative, parallel and mixed method study was conducted at the Community Oncology Centre, Ahmedabad, among 68 terminally ill cancer patients as per inclusion criteria; who were receiving hospice (HS)-based and home (HO)-based palliative care under 2 months permitted by the Indian Council of Medical Research. In this parallel and mixed method study, qualitative findings were supplemented by quantitative data with both components executed simultaneously. Interview data were recorded by taking extensive notes during interviews along with an audio recording. Interviews were transcribed verbatim and a thematic approach was adopted. QoL questionnaire ('FACIT© System') was used for the assessment of QOL in terms of four dimensions. Data were analysed using the appropriate statistical test on Microsoft Excel. The qualitative data (primary component) analysed under five themes - staff behaviour, comfort and peace, enough and consistent care, nutrition and moral support, in the present study favours a HS-based setting more than a HO-based setting. Among all four subscale scores, physical well-being and emotional well-being subscale scores were statistically significantly associated with the place of palliative care. Functional Assessment of Cancer Therapy-General (FACT-G) total score was high among patients getting HO-based palliative (mean = 67.64) care than HS-based palliative care (mean = 56.56) and the difference between total FACT-G scores was statistically significant (unpaired t-test = 2.20, P = 0.03). Overall, with the primary component favouring HS care and higher scores obtained in HO-based patients, the present study advocates the necessity for palliative services to expand their coverage regardless of whether they are provided at HS or HO, as it has improved the QOL of cancer patients significantly.

Health-related quality of life in patients with resectable undifferentiated pleomorphic sarcoma treated with neoadjuvant checkpoint blockade in a single institution randomized phase II clinical trial.

11544 Background: In SARC028, patients with undifferentiated pleomorphic sarcoma (UPS) had a 40% overall response rate to pembrolizumab. Based on this, we conducted a randomized, phase II, non-comparative trial of combination nivolumab (nivo/RT) and ipilimumab (ipi/nivo/RT) and demonstrated an 89% major pathologic response. Here, we report the health-related quality of life (HRQoL) metrics. Methods: In this study (NCT03307616), patients with resectable UPS were randomized (1:1) to receive one dose of nivo (3mg/kg) or one dose of combination nivo (3 mg/kg) and ipi (1 mg/kg), followed by combination of nivo (3 doses, 3mg/kg every 2 weeks) plus 50 Gy in 25 fractions (both arms). HRQoL was assessed using the MD Anderson Symptom Inventory (MDASI), European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLC) Core 30, and the Functional Assessment of Cancer Therapy – General (FACT-G) questionnaires. Questionnaire completion rates were calculated using the number of patients with at least one baseline and post-baseline assessment. Analyses included mean change from baseline scores to week 11 (preoperative) and week 54 (postoperative). Results: Ten patients were randomized from October 2017 to February 2020. HRQoL were collected at baseline (n = 10) and at week 11 for five (83%) nivo/RT and three (60%) ipi/nivo/RT patients. Three (60%) nivo/RT and three (100%) ipi/nivo/RT patients had week 54 assessments. MDASI scores indicative of symptom severity and interference of daily life both decreased for patients undergoing ipi/nivo/RT (0.8→0.67 and 0.9→0.46, respectively) while both increased in the nivo/RT group (1.6→2.22 and 1.9→3.33, respectively). Both arms had similar increases at 54 weeks. Patients undergoing ipi/nivo/RT experienced a greater decline in EORTC-QLC global health status at 54 weeks than those undergoing single agent therapy (-22.92 vs -8.33). The mean change in total FACT-G score did not differ between the two arms at 11 weeks (-4.0 vs -4.5), however, there was a significant decline for patients undergoing ipi/nivo/RT at 54 weeks (-20.3 vs -5.7). Conclusions: For patients with resectable UPS, combination immune checkpoint blockade with ipi/nivo/RT is associated with an improvement in short term HRQoL compared to single-agent nivo/RT. This finding warrants further study with more patients, controlling for baseline symptom scores. Combination therapy was associated with a slower recovery to baseline function, with ongoing decline in HRQoL at 54 weeks post treatment. Our study demonstrates the feasibility of collecting HRQoL metrics, which can be key factors in guiding patient management decisions. Clinical trial information: NCT03307616.

Quality of Life Outcomes Following Stereotactic Body Radiotherapy in Patients with Oligo-Metastatic Disease: A Systematic Review and Meta-Analysis

<h3>Purpose/Objective(s)</h3> The management of oligo-metastatic disease (OMD) is evolving, with increasing data supporting the use of stereotactic body radiotherapy. The aim of this systematic review and meta-analysis is to analyses health related quality of life (HRQOL) outcomes and the side-effects of SBRT in patients with OMD. <h3>Materials/Methods</h3> We searched MEDLINE, Epub Ahead of Print, EMBASE, Cochrane CT, Cochrane SR, Emcare, and PsycInfo databases (from inception to March 2020). Randomized clinical trials (RCTs) or observational studies were included if HRQOL outcomes were reported from patients with defined OMD (£5 metastases) who received SBRT as metastasis-directed therapy, and who completed validated HRQOL questionnaires at baseline and 12-months. Meta-analysis using weighted mean difference was performed to estimate a difference between baseline and 12-month scores. Secondary outcome, calculated by the pooled incidence rate approach using the inverse variance method, was the estimated event rate of clinically significant Common Terminology Criteria for Adverse Events (CTCAE) grade 2-4 and grade 5 toxicity, expressed per person-time of follow-up. Authors of studies included were contacted to obtain additional information. Methods adhered to PRISMA guidelines. <h3>Results</h3> Four of 7,545 studies screened were eligible for inclusion. Two studies were phase II RCTs and two were prospective single arm studies. Among 277 patients who received SBRT, median follow-up was 31 months (range 24–41 months). Two studies included only prostate cancer patients and two studies included mixed histologies. Two studies measured European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and two measured Functional Assessment of Cancer Therapy – General (FACT-G) scores. Using a fixed effects model, the mean change in 12-month EORTC QLQ-C30 global health QOL score from baseline demonstrated a statistically significant decline (pooled weighted mean difference -5.2, 95% CI -9.3 to -1.2, both prostate cancer studies, 57 patients total). Meta-analysis of total FACT-G scores in the other two studies was not possible as mean difference results for one study were unavailable. For the available multi-histology study, no statistically significant difference was seen in baseline to 12-month mean FACT-G total scores in the SBRT arm. We estimated an event rate of 0.06 (95% CI: 0.024, 0.15) CTCAE grade 2-4 toxicities per person-year and 0.008 (95% CI: 0.002, 0.031) grade 5 toxicities per person-year. <h3>Conclusion</h3> Although a statistically significant decline in the EORTC QLQ C30 global health/QOL measure was seen, it was small and unlikely to be of clinical importance. Rates of SBRT-related clinical toxicities are low. There is limited QOL data published for patients with OMD, with varying HRQOL tools used.

Associations between patient-centered communication and quality of life in patients with ovarian cancer.

12120 Background: Patient-centered communication (PCC) occurs when clinicians respond to patients’ needs, preferences, concerns, and emotions. The National Cancer Institute (NCI) Framework for PCC in Cancer Care highlights the potential of PCC to improve health-related quality of life (HRQoL), but to date few studies have empirically examined associations between PCC and HRQoL in patients with ovarian cancer. We assessed associations between perceived PCC and HRQoL in patients with ovarian cancer. Methods: Cross-sectional, descriptive survey of English-speaking adults with ovarian cancer recruited both online and from one NCI-designated cancer center. We assessed perceived PCC with the Patient-Centered Communication in Cancer Care (PCC-Ca)-36 and HRQoL with the Functional Assessment of Cancer Therapy: General (FACT-G). We used simple linear regression to identify univariate associations between participant characteristics, PCC-Ca-36 total, FACT-G total, and FACT-G subscale (physical, social and family, emotional, and functional well-being) scores. We identified significant predictors of FACT-G total and subscale scores by entering variables associated with each outcome at p ≤ 0.25 into a multiple linear regression model and using backward elimination. Results: One hundred seventy-six participants completed the survey. In multivariable analyses, older age, working (vs. not working), no current treatment (vs. any current treatment), and greater perceived PCC were associated with better overall HRQoL. Working and no current treatment were associated with better physical well-being. Older age, not being cared for by a gynecologic oncologist (vs. being cared for by a gynecologic oncologist), and greater perceived PCC were associated with better social and family well-being. Older age, being recruited online (vs. in clinic), and greater perceived PCC were associated with better emotional well-being. Older age, working, rural residence (vs. not), no current treatment, and greater perceived PCC were associated with better functional well-being (all p ≤ 0.05). Conclusions: Greater perceived PCC was significantly associated with better overall HRQoL and better social, emotional, and functional well-being in this cross-sectional study of patients with ovarian cancer. The NCI Framework for PCC in Cancer Care posits that PCC promotes HRQoL by strengthening the therapeutic alliance, enhancing social support, and improving patient knowledge. Although PCC is theorized to promote patient self-management, PCC was not significantly associated with physical well-being in this sample. Future research should (a) identify mediators of the associations between PCC and HRQoL; (b) examine inter-individual variability in characteristics that may compromise HRQoL; (c) and examine associations between PCC and HRQoL over time.

Quality of life in patients with mycosis fungoides and Sézary syndrome undergoing low-dose total skin electron beam therapy with or without maintenance therapy

Quality of life in patients with mycosis fungoides and Sézary syndrome undergoing low-dose total skin electron beam therapy with or without maintenance therapy

Feasibility and Acceptability of Digital Legacy-Making: An Innovative Story-Telling Intervention for Adults With Cancer.

This study examined the feasibility, burden and acceptability of a legacy-making intervention in adults with cancer and preliminary effects on patient quality-of-life (QOL) measures. We conducted a Stage IB pilot, intervention study. The intervention was a digital video legacy-making interview of adults with advanced cancer to create a digital video of their memories and experiences. Baseline and post-video QOL assessments included: Functional Assessment of Cancer Therapy-General (FACT-G), Patient Dignity Inventory (PDI), Hospital Anxiety and Depression Scale (HADS), and Emotional Thermometers for distress, anxiety, anger, help and depression. Participants received a final copy of the digital video for distribution to their families. Adults (n = 16) ages 38-83 years old with an advanced or life-limiting cancer diagnosis completed an intervention. Feasibility and acceptability was strong with 0% attrition. While the pilot study was not powered for quantitative significance, there were changes from baseline to post-intervention in the participants' total or subscale FACT-G scores, PDI, HADS anxiety or depression scores, and Emotional Thermometer scores. A digital video legacy-making intervention is feasible for adults with cancer without significant negative outcomes for individuals completing the study. It remains unclear whether this intervention contributes to positive quality of life outcomes.

Beyond Mortality: Health-Related Quality of Life in Adolescent and Young Adult Patients with Lymphoma: A Longitudinal Study

Introduction: Lymphoma is the most common cancer among adolescents and young adults (AYAs). We examined changes in health-related quality of life (HRQoL) and its predictors in AYA patients (pts). Patients and Methods: We identified AYA pts (aged 18-39) enrolled 2002-2015 in a prospective cohort of pts with newly diagnosed lymphoma from the University of Iowa and Mayo Clinic Molecular Epidemiology Resource, part of the Lymphoma Epidemiology of Outcomes cohort. Enrollment could occur prior to or after initiation of treatment. We measured HRQoL using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire at baseline, 12, and 24 months. FACT-G yields five HRQoL domain scores: emotional well-being (EWB), functional WB (FWB), physical WB (PWB), social/family WB (SFWB), and total FACT-G score (a sum of the domains). Pts completing &amp;lt;80% of the FACT-G questions were excluded. Linear mixed models with random subject intercepts estimated changes in FACT-G scores from baseline. The covariates in multivariate analysis were lymphoma subtype, stage, and treatment. Interaction effects between treatment (chemotherapy and/or radiation) and subtype were added to the model. We calculated effect sizes (ES) for the magnitude of mean change scores: 0.2, 0.5, and 0.8 were considered small, medium, and large ESs, respectively. Only ESs for mean score differences with p&amp;lt;0.05 are reported. Results: We identified 467 pts; median age at diagnosis was 30 years, median follow up was 5.9 years. 53% of pts completed the baseline FACT-G assessment pre-treatment, 47% completed after treatment began. Pts assessed after treatment initiation had lower baseline total FACT-G (ES -0.25), FWB (ES -0.27), and PWB scores (-0.46); but baseline EWB was higher in pts assessed prior to treatment (ES 0.20). There was no association between HRQoL scores at baseline or over time and lymphoma subtype, stage, or treatment type, or interactions. Total FACT-G scores modestly improved over time, ES 0.32 at 1 year and ES 0.45 at 2 years after enrollment. EWB, FWB, and PWB also improved over time (ES 0.36, 0.44, 0.30 at 1 year; and 0.49, 0.56, 0.38 at 2 years, respectively). SFWB scores slightly worsened over time (ES -0.24 at 1 year and -0.12 at 2 years). Conclusions: AYA pts with lymphoma had higher baseline total FACT-G scores, FWB and PWB prior to therapy initiation compared to after initiation. HRQoL improved from diagnosis through the first 2 years after diagnosis, except for SFWB. Neither stage, lymphoma subtype, nor treatment type affected change in HRQoL. The lack of improvement in SFWB suggests social interventions and future studies should examine factors impacting SFWB in AYA pts. Disclosures Cohen: Genentech, BMS, Novartis, LAM, BioInvent, LRF, ASH, Astra Zeneca, Seattle Genetics: Research Funding; Janssen, Adicet, Astra Zeneca, Genentech, Aptitude Health, Cellectar, Kite/Gilead, Loxo: Consultancy. Flowers:Leukemia and Lymphoma Society: Membership on an entity's Board of Directors or advisory committees; National Cancer Institute: Research Funding; AbbVie: Consultancy, Research Funding; Cancer Prevention and Research Institute of Texas: Research Funding; Eastern Cooperative Oncology Group: Research Funding; Burroughs Wellcome Fund: Research Funding; Kite: Research Funding; V Foundation: Research Funding; TG Therapeutics: Research Funding; Millennium/Takeda: Consultancy, Research Funding; Acerta: Research Funding; Spectrum: Consultancy; Pharmacyclics/Janssen: Consultancy; Karyopharm: Consultancy; OptumRx: Consultancy; Gilead: Consultancy, Research Funding; Genentech, Inc./F. Hoffmann-La Roche Ltd: Consultancy, Research Funding; Denovo Biopharma: Consultancy; Celgene: Consultancy, Research Funding; BeiGene: Consultancy; Bayer: Consultancy. Cerhan:BMS/Celgene: Research Funding; NanoString: Research Funding.

Using Patient-Reported Outcomes to Describe the Patient Experience on Phase I Clinical Trials.

BackgroundSymptoms are common among patients enrolled in phase I trials. We assessed the validity of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) items in relation to previously validated assessments of quality of life and psychological distress. We used data from a randomized trial testing a palliative care support intervention for patients enrolled on phase I trials.MethodsPatients (n = 479) were accrued to the parent study prior to initiating a phase I clinical trial with data collected at baseline, 4, and 12 weeks. We determined the correlation of PRO-CTCAE with distress level, Functional Assessment of Cancer Therapy - General (FACT-G) total, and subscale domain scores.ResultsPatients were predominantly female (56.8%) and older than age 60 years, and 30.7% were from minority populations. The correlation coefficient for distress level for all PRO-CTCAE items was small to moderate (Pearson r = 0.33-0.46). Pearson correlation coefficient for FACT-G total was moderate (r = -0.45 to -0.69). Stronger associations were noted for mood items of the PRO-CTCAE only (with distress level, r = 0.55-0.6; with FACT-G, r = -0.54 to -0.6). PRO-CTCAE symptom interference scores had the strongest correlation with distress level (Pearson r = 0.46) and FACT-G total (Pearson r = -0.69). Correlations between PRO-CTCAE items and corresponding FACT-G (total and subscales) and distress levels reached statistical significance for all items (P <.001).ConclusionEvidence demonstrates validity of PRO-CTCAE in a heterogeneous US sample of patients undergoing cancer treatment on phase I trials, with small to moderate correlations with distress level for all PRO-CTCAE items and moderate correlations with quality of life as measured by FACT-G total.

Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study

BackgroundBrentuximab vedotin was approved for adult patients with CD30-expressing cutaneous T-cell lymphoma treated with prior systemic therapy based on improved response rates and progression-free survival with brentuximab vedotin (1.8 mg/kg once every 3 weeks; ≤16 cycles) versus physician's choice (methotrexate/bexarotene; ≤48 weeks) in the phase III ALCANZA study. Quality of life (QoL) in ALCANZA patients was also examined. MethodsQoL measures in ALCANZA were based on the Skindex-29, Functional Assessment of Cancer Therapy-General (FACT-G) and European QoL 5-dimension (EQ-5D) questionnaires. ResultsMean maximum reduction from the baseline Skindex-29 symptom domain score (key secondary end-point) was greater with brentuximab vedotin than physician's choice (–27.96 versus –8.62); the difference, –18.9 (95% confidence interval –26.6, –11.2; adjusted p < 0.001), exceeded the study-defined minimally important difference (9.0–12.3). Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus –2.29). EQ-5D changes were also comparable between arms. Among brentuximab vedotin-treated patients with peripheral neuropathy (PN), mean maximum reduction in Skindex-29 symptom domain was –35.54 versus –11.11 in patients without PN. PN had no meaningful effect on FACT-G and EQ-5D QoL scores. ConclusionsIn summary, brentuximab vedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffected by the presence of PN in brentuximab vedotin-treated patients. Clinical trial registrationNCT01578499.

Validation of the 7-item Functional Assessment of Cancer Therapy-General (FACT-G7) as a short measure of quality of life in patients with advanced cancer.

Assessing quality of life is essential for individuals with advanced cancer, but lengthy assessments can be burdensome. The authors investigated the psychometric characteristics of the FACT-G7, a 7-item quality-of-life measure derived from the Functional Assessment of Cancer Therapy-General (FACT-G) scale, in advanced cancer. Data were obtained from outpatients with advanced cancer who were enrolled in a randomized controlled trial of early palliative care. At baseline, 228 intervention participants and 233 control participants (N=461) completed the FACT-G and measures of symptom severity, quality of life near the end of life, problematic medical communication, and satisfaction with care. Follow-up measures were administered monthly for 4months. The FACT-G7 showed good internal consistency (Cronbach α=.72-.80), and its single-factor structure was supported. It correlated strongly with the FACT-G total, physical, and functional indices and with symptom severity (absolute r=0.73-0.92); more moderately with the FACT-G emotional index and with symptom impact and preparation for the end of life (r=.40-.71); and least with the FACT-G social/family index and with relationship with health care provider, life completion, problematic medical communication, and care satisfaction measures (absolute r=.26-.44). Eastern Cooperative Oncology Group performance status groups differed on FACT-G7 scores, as expected (all P<.001). Improvements in FACT-G7 scores in the intervention group compared with the control group at 3-month (P=.049) and 4-month (P=.034) follow-up supported responsiveness to change and somewhat greater sensitivity than the FACT-G scores. The FACT-G7 is a valid, brief measure particularly of the physical and functional facets of quality of life. It may enable rapid quality-of-life assessments in patients with advanced cancer.

Oxylipins Correlate with Quality of Life in Women Taking Aromatase Inhibitors for Breast Cancer

Abstract The purpose of this study was to determine if oxylipins – oxygenated bioactive lipid metabolites of ω-3 and ω-6 fatty acids with varying roles in inflammation and pain – correlate with aromatase inhibitor-associated arthralgia (AIA) and quality of life (QOL) in early stage breast cancer (ESBC) patients. Methods: ESBC patients on AI therapy were enrolled to an open-label study of sulindac, a non-steroidal anti-inflammatory drug (NSAID), for 12 months (n = 47). Pre-intervention arthralgia and physical function were assessed using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire, where higher scores indicate worse symptoms. The Functional Assessment of Cancer Therapy – General (FACT-G) questionnaire was used to assess QOL, where higher scores indicate better QOL. A total of 53 plasma oxylipins in plasma were quantified by mass spectrometry. Pearson's correlation was used to measure the association between pre-intervention oxylipin concentrations, arthralgias and QOL. Results: Prior to initiating sulindac, baseline levels of 17 oxylipins were found to be significantly correlated with QOL scales. This included inverse associations between QOL and seven pro-inflammatory products of ω-6 fatty acid metabolism. Notably, prostaglandin E2, the primary target of NSAIDs, was negatively correlated with Social Well-Being (rho = −0.30; P = 0.04). Conversely, resolvin D1, a potent anti-inflammatory lipid, was positively associated with Total FACT-G (rho = 0.31; P = 0.03) and Emotional Well-Being (rho = 0.37; P = 0.01). Two ω-3 metabolites with unknown mechanisms were correlated with both QOL and WOMAC; 19,20-DiHDPE was positively correlated with Total (rho = 0.34; P = 0.02) and Social FACT-G (rho = 0.32; P = 0.03), and inversely with Total WOMAC (rho = -0.303; P = 0.04) and Stiffness (rho = −0.32; P = 0.03); and 5(6)-DiHETE was inversely correlated with Social FACT-G (rho = −0.33; P = 0.02) and positively with Total WOMAC (rho = 0.31; P = 0.04). Conclusions: This is the first evidence that plasma oxylipin metabolites of ω-3/ω-6 fatty acids correlate with QOL and arthralgia symptoms in patients on AIs and suggests oxylipins as a potential novel target for improving QOL and adherence to AI therapy in patients with ESBC.

Recurrence or neurological loss? Resection mode selection for patients with large sacral chordoma: an analysis of prognostic factors and quality of life.

Surgical resection represents the main therapeutic method for sacral chordoma, but plans for resection mode must weigh neurological loss against complete tumor excision, a difficult balance to strike. The purpose of this study was to provide useful information contributing to surgical decision making in sacral chordoma. A retrospective review was performed on 47 patients with large sacral chordoma. Prognostic factors affecting recurrence-free survival (RFS) and overall survival (OS) were analyzed using the Kaplan-Meier method and Cox proportional hazards model. Quality of life was assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire and compared using Student's t test. Resection mode was the independent prognostic factor affecting RFS, while independent prognostic factors affecting OS were resection mode and postoperative recurrence. As for quality of life, the en bloc resection group showed a higher score in emotional well-being, while the piecemeal resection group scored better in function well-being. No significant difference was identified in total the FACT-G score between two groups. On the one hand, en bloc resection showed huge advantages in disease control for sacral chordoma. On the other hand, despite the unsatisfaction in functional well-being, en bloc resection did not sacrifice quality of life significantly in terms of the total FACT-G score.

Patient-Reported Outcomes in Systemic Light-Chain Amyloidosis

Background: Patients with systemic light-chain (AL) amyloidosis have a high symptom burden which can negatively impact their health-related quality of life (HRQoL). However, there is a lack of data on patient-reported outcomes (PROs) in this population in the current era of effective plasma cell directed therapies. The primary objectives of our study were to assess baseline HRQoL using FACT-G (Functional Assessment of Cancer Therapy-General) and PROMIS-GH (Patient Reported Outcomes Measurement Information System-Global Health), evaluate the degree of correlation between FACT-G and PROMIS-GH, and compare HRQoL by hematologic response to first-line therapy in systemic AL amyloidosis.Method: This was an observational study using the Cleveland Clinic Knowledge Program database, which contains HRQoL data captured at outpatient visits. FACT-G was administered every 90 days since its implementation on September 2012. PROMIS-GH was implemented in October 2015, initially administered every 30 days and subsequently every 90 days since July 2017.Results: A total of 81 patients with systemic AL amyloidosis diagnosed between September 2012 and December 2017 and ≥1 HRQoL measurement were included in our analysis. The median age at diagnosis was 64 years. Cardiac involvement at diagnosis was present in 49% of patients. The most common induction therapy was Bortezomib-Cyclophosphamide-Dexamethasone (86%). Autologous stem cell transplantation was performed in 38% of patients.Data on HRQoL at baseline (≤2 months from diagnosis) using FACT-G was available for 43 patients. The mean FACT-G total score at baseline was 74 (standard deviation [S.D.] ±15). In comparison, the mean FACT-G total score for general US population is 80.1 (±18.1) and that of US cancer patients is 79.3 (±17.0) [Normative data from Pearman et al; Cancer. 2014]. Maximal HRQoL deficit was seen in the functional well-being (FWB) domain of FACT-G, with the mean score being >0.5 S.D. below that of the general population (Table 1). Data on HRQoL at baseline using PROMIS-GH was available for 18 patients. There was a significant deficit in global physical health (GPH) compared to the general population, with a mean T-score of 37.7 (±7.8) [Mean T-score in general US population being 50±10]. The mean T-score for global mental health (GMH) was 44.4 (±6.7).A total of 72 patients had 128 outpatient visits where FACT-G and PROMIS-GH were captured concurrently (range, 1-4 visits per patient). Using Cohen's criterion, GPH domain of PROMIS-GH had a large and statistically significant correlation with FACT-G total (r=0.66), physical well being (PWB) (r=0.77) and FWB (r=0.66) scores. PROMIS GMH domain also had a strong and statistically significant correlation with FACT-G total (r=0.73), PWB (r=0.60), emotional well-being (EWB) (r=0.64) and FWB (r=0.73) scores. The scatterplots for correlation between PROMIS-GH domains and FACT-G total score is shown in Figure I.At follow-up, a total of 50 patients had data on best hematologic response and HRQoL assessment. Patients achieving a complete response (CR) to first-line therapy had a significantly superior FACT-G score at all domains compared to those with less than CR or no response. Maximal benefit in complete responders was noted in the FWB domain of FACT-G (Mean score ≥2 S.D. higher than patients with less than CR or no response; P=0.002).Conclusion: Patients with AL amyloidosis have a worse HRQoL at diagnosis compared to US cancer and general adult population. Deficit in HRQoL was most prominent in the FWB domain of FACT-G and GPH domain of PROMIS-GH. Most domains of FACT-G and PROMIS-GH had strong and significant correlation. Patients achieving a CR to first-line therapy had significantly superior HRQoL at all FACT-G domains. Clinical trials in AL amyloidosis should include patient-reported HRQoL as a key endpoint and focus on the domains of physical health and functioning to assess meaningful benefit of novel therapies. Psychometric validation of FACT-G and PROMIS-GH in AL amyloidosis would be helpful in generating robust PRO data in future studies. DisclosuresMajhail:Anthem, Inc.: Consultancy; Incyte: Honoraria; Atara: Honoraria.

Sexual Function and Quality of Life Among Patients With Endometrial Cancer After Surgery.

The aim of this study was to evaluate the sexual function and quality of life (QOL) and identify their associated factors in survivors of endometrial cancer. The participants in this study were survivors of endometrial cancer who visited the gynecological outpatient department for routine surveillance from June 2014 to May 2015. The QOL and sexual function were measured using the Functional Assessment of Cancer Therapy-General (FACT-G) and Female Sexual Function Index questionnaires. A score less than 26.55 was defined as female sexual dysfunction (FSD). Multivariate analysis and logistic regression were performed to identify the factors associated with QOL and sexual function. A total of 118 women completed the questionnaires. The results revealed that 68.6% of the patients had FSD and that 55.9% of the patients never had sexual intercourse with their partners after surgery. Age, followed by time after surgery, radiotherapy, and consultation, was significantly correlated with FSD. The median score of the FACT-G was 86 (range, 41-108). Chemotherapy and marital status were found to significantly impair physical and social/family well-being, respectively (P < 0.05), and monthly income was identified as a factor that significantly affected the total FACT-G scores. The risk factors associated with FSD and QOL need to be studied in greater detail. Prospective researches that evaluate the effects of clinical psychological intervention on sexual function may be needed in the future.

The quality of life following allogeneic hematopoietic stem cell transplantation - a multicenter retrospective study.

Although allogeneic haematopoietic stem cell transplantation (allo-HSCT) offers a unique curative potential, it may be connected with high treatment-related morbidity and mortality. Besides many organ complications, allo-HSCT may significantly affect quality of life (QOL). Between January 2011 and December 2012, five hundred and ninety patients (pts) from 6 transplant centers in the Czech Republic filled in the questionnaire for the quantitative measurement of QOL using Functional Assessment of Cancer Therapy-General (FACT-G) version 4. Study cohort characteristics were as follows: 325 males, 340 pts received myeloablative conditioning, 383 pts received PBPC, representation of diagnoses; acute leukemia (n=270), bone marrow failure (n=36), chronic myeloid leukemia (n=74), myelodysplastic/myeloproliferative syndrom (n=110), lymphoproliferative disease (n=93). The median age at allo-HSCT was 43 years (range: 1.7 - 71.0), the median time from allo-HSCT to questionnaire completing was 3.8 years (range: - 0.2 - 21.6). The earliest allo-HSCT was performed in November 1989, the last in September 2012. In this retrospective study, we investigated the impact of various factors on the QOL after allo-HSCT: age, gender, diagnosis, type of conditioning, time from diagnosis to allo-HSCT, disease stage, graft type, donor type, time from allo-HSCT to questionnaire completing, GVHD, relapse. Only data from patients who were more than 3 months after allo-HSCT were used for the multivariate analysis. The overall results of the total FACT-G score (median=85.0; range: 29-108) as well as the results of each specific dimension - PWB (median=23.0; range: 5-28), SWB (median=24.0; range: 7-28), EWB (median= 19.0; range: 4-24), FWB (mean=21.0; range: 2-28) showed a value in the highest quartile of the possible evaluation. In multivariate analysis, an inferior QOL score was reported for patients with aGVHD (p=0.002), cGVHD (p<0.001), QOL decreased with increasing age (p=0.048) and increased with time elapsed since allo-HSCT (p<0.001).Allogeneic HSCT represents an important intervention into the overall integrity of the organism. In particular, the development of GVHD can cause very serious organ, but also mental problems which can significantly reduce the QOL. The QOL is steadily increasing with increasing interval from allo-HSCT but improvement and disappearance of these complications may take many years, and sometimes these effects may probably persist permanently.